Dental Caries in ChildrenNCT04195022
Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth
A study testing Dental Restoration with Chemically activated Composite resin Alkasite and Dental Restoration with Bulk fill resin composite in people with Dental Caries in Children, run by Faculty Sao Leopoldo Mandic Campinas at 1 site in Brazil.
Trial summary
Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Dental Restoration with Chemically activated Composite resin Alkasite and Dental Restoration with Bulk fill resin composite
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2019to 30 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children will be included who have at least one posterior tooth with atypical caries lesion.
Who cannot join
- Patients with special needs will be excluded, with general health conditions that may affect the oral cavity, non-cooperating in relation to the examination, which use orthodontic apparatus and the parents/guardians or children not to consent to their participation in the study. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula close to the tooth, furcation or cervical injury, teeth with restorations, sealants or enamel formation defects will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Faculty Sao Leopoldo Mandic
Campinas, São Paulo, 13045755
Jose Carlos P Imparato, PhD, +551935183601, jimparato@usp.br
Ana Paula M de Araújo
About this study
Official title: Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth - A Non-inferiority Randomized Clinical Trial
Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the lesions. Patient-centered outcomes will also be evaluated.
- Conditions
- Dental Caries in Children
- Being tested
- Dental Restoration with Chemically activated Composite resin Alkasite, Dental Restoration with Bulk fill resin composite
- Keywords
- Dental caries, Deciduous teeth, Permanent dental restoration
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Restoration with Chemically activated Composite resin AlkasiteProcedure or surgery
Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.
Dental Restoration with Bulk fill resin compositeProcedure or surgery
Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with bulk fill resin composite.
| Study group | Role | What they receive |
|---|---|---|
| Chemically activated Composite resin Alkasite | Experimental | Single placement of composite resin on atypical cavities. Receives: Procedure: Dental Restoration with Chemically activated Composite resin Alkasite |
| Bulk fill resin composite | Active comparator | Single placement of Bulk fill resin composite on atypical cavities. Receives: Procedure: Dental Restoration with Bulk fill resin composite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of restoration
To evaluate the survival of restoration by clinical examination with FDI index.
Measured: 12 months after treatment.
Secondary outcomes (8)
Caries lesion progression
For the evaluation of caries progression, the interproximal radiographic examination will be used to verify an increase of radiolucent image under restoration.
Measured: 12 months after treatment.
Secondary caries lesion or on the surface adjacent to the restored tooth
Presence of caries lesion on the surface adjacent to the restored tooth or on the margins of the restoration by means of visual Clinical Examination.
Measured: 12 months after treatment.
Perception of children and parents/guardians
To evaluate the satisfaction of the children in relation to the treatment performed. The questionnaire will be used "Child's and parent's questionnaire about teeth appearance".
Measured: 6 months after treatment.
Operator perception
It will be employed a questionnaire after the completion of the treatment performed. It will also be added a question about the behavior of children during the procedure, which will be categorized as - great behavior, regular or bad.
Measured: 6 months after treatment.
Parents/Guardians Satisfaction
The parents/guardians will be questioned about the satisfaction regarding the treatment performed in the child. The answer will be scored by a likert scale.
Measured: 6 months after treatment.
Child discomfort
The child will also be questioned as to the discomfort in relation to the treatment performed. For this will be used the scale of faces of Wong-Baker.
Measured: Immediately after the treatment.
Post Operative sensitivity of the child
The child will also be questioned about the sensitivity of the restorative procedure. For this, the Wong-Baker face scale will be used.
Measured: 7 days after treatment.
Oral health-related quality of life
The validated Brazilian version of Early Childhood Oral Health Impact Scale (ECOHIS) will be applied to children and should be answered by their parents.
Measured: 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start1 Sep 2019
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Faculty Sao Leopoldo Mandic Campinas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195022
- Sponsor's protocol ID
- SLM2990II
- Status last verified
- Dec 2019
- First submitted
- 30 Sep 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Chemically Activated Composite Resin Alkasite With Resin Composite in Atypical Caries Lesions of Deciduous Teeth - A Non-inferiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04195022
- Acronym / sponsor ID
- SLM2990II
- Conditions
- Dental Caries in Children
- Keywords
- Dental caries, Deciduous teeth, Permanent dental restoration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Faculty Sao Leopoldo Mandic CampinasUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the lesions. Patient-centered outcomes will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemically activated Composite resin Alkasite | Experimental | Procedure: Dental Restoration with Chemically activated Composite resin AlkasiteSingle placement of composite resin on atypical cavities. |
| Bulk fill resin composite | Active comparator | Procedure: Dental Restoration with Bulk fill resin compositeSingle placement of Bulk fill resin composite on atypical cavities. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children will be included who have at least one posterior tooth with atypical caries lesion.
Key exclusion criteria (1 listed)
- Patients with special needs will be excluded, with general health conditions that may affect the oral cavity, non-cooperating in relation to the examination, which use orthodontic apparatus and the parents/guardians or children not to consent to their participation in the study. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula close to the tooth, furcation or cervical injury, teeth with restorations, sealants or enamel formation defects will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental Restoration with Chemically activated Composite resin AlkasiteSelective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite. | Procedure or surgery | Chemically activated Composite resin Alkasite |
| Dental Restoration with Bulk fill resin compositeSelective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with bulk fill resin composite. | Procedure or surgery | Bulk fill resin composite |
Primary outcome
Survival of restoration
Time frame: 12 months after treatment.
To evaluate the survival of restoration by clinical examination with FDI index.
8 secondary outcomes
Caries lesion progression
Time frame: 12 months after treatment.
Secondary caries lesion or on the surface adjacent to the restored tooth
Time frame: 12 months after treatment.
Perception of children and parents/guardians
Time frame: 6 months after treatment.
Operator perception
Time frame: 6 months after treatment.
Parents/Guardians Satisfaction
Time frame: 6 months after treatment.
Child discomfort
Time frame: Immediately after the treatment.
Post Operative sensitivity of the child
Time frame: 7 days after treatment.
Oral health-related quality of life
Time frame: 6 months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
Related trials for Dental Caries in Children
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
Not yet recruiting
Effect of Bioactive Glass Varnish on Salivary Parameters in Children: Randomized Controlled Trial
Prevention of Dental Caries
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Restoration with Chemically activated Composite resin Alkasite and Dental Restoration with Bulk fill resin composite in people with Dental Caries in Children, run by Faculty Sao Leopoldo Mandic Campinas at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of restoration (time frame: 12 months after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.